A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:December 2010
End Date:November 2012
Contact:Quintiles Ltd
Phone:44 1344 708000

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A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure


The purpose of this study is to evaluate the efficacy of systemically administered AZD4017,
compared with placebo, over a 28-day period in patients with raised intra-ocular pressure
(IOP).     


Inclusion Criteria:

- Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary
open-angle glaucoma (POAG), with IOP >20 mmHg and ≤36 mmHg in the study eye, and is
currently prescribed a stable dose of a single anti-glaucoma medication that began at
least 30 days prior to the screening visit; OR

- Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP
≥22 mmHg and ≤36 mmHg in the study eye while not on anti-glaucoma medication

- Male patients must be willing to use barrier contraception with spermicide, ie,
condoms, from the day of first dosing until 3 months after dosing with IP

- Placebo treatment for duration of the study must not be considered detrimental to the
patient

Exclusion Criteria:

- Have uncontrolled intra-ocular hypertension (>36 mmHg)

- Have experienced a significant visual field loss or showed evidence of progressive
visual field loss within the last year (as defined by >1 dB/yr average loss or vision
threatening new defect)

- Have had severe eye trauma at any time
We found this trial at
6
sites
436
mi
from 43215
Atlanta, GA
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400
mi
from 43215
Allentown, PA
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302
mi
from 43215
Asheville, NC
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362
mi
from 43215
Chattanooga, TN
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620
mi
from 43215
Kansas City, KS
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1951
mi
from 43215
San Diego, CA
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